UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy
Title of the study (Brief title)	Pulse wave transit time measurements of cardiac output in patients undergoing robot-assisted radical prostatectomy
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The efficacy of pulse wave transit time in patients undergoing robot-assisted radical prostatectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The aim of this study is to evaluate the ability of PWTT compared with cardiac output measured by APCO in patients undergoing robot-assisted radical prostatectomy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	The patients that robot-assisted radical prostatectomy was planned under general anesthesia.
Key exclusion criteria	Atrial fibrillation Moderate or severe aortic stenosis Moderate or severe aortic regurgitation The arterial catheterisation is the patient of contraindication.
Target sample size	100

Research contact person
Name of lead principal investigator	Takahiro Sguiura
Organization	National hospital organization Tokyo medical center
Division name	Anesthesiology
Address	2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL	03-3411-0111
Email	sugiura.takahiro@navy.plala.or.jp

Public contact
Name of contact person	Takahiro Sugiura
Organization	National hospital organization Tokyo medical center
Division name	Anesthesiology
Address	2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL	03-3411-0111
Homepage URL
Email	sugiura.takahiro@navy.plala.or.jp

Sponsor
Institute	Ntional hospital organization Tokyo medical center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 07 Month 07 Day
Anticipated trial start date	2017 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	From records such as an electrocardiogram, the oxygen saturation in the practice, we evaluate pulse wave transmission time retrospectively.

Management information
Registered date	2017 Year 08 Month 18 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031553